A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects
The purpose of this research study to test the effectiveness of a study medication to
increase how fast a solution called lactated Ringer’s is absorbed when put under the skin
subcutaneously. The medication to be studied is an enzyme called hyaluronidase, and is a
human recombinant form of the enzyme. The drug company name for this medication is Hylenex.
Hylenex was currently an investigational medication at the initiation of the study, but
received FDA approval during the study. An investigational medication is a medication or
formulation of a medication that is not approved by the United States Food and Drug
Administration for use in this country but may be used in studies such as this one.
A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase
This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study
comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC)
administered, viscous antibody solution of with and without human recombinant hyaluronidase
(rHuPH20) in volunteer subjects.
The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous
antibody with rHuPH20 will be comparable or shorter than the time required for the injection
Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children
The aim of the study is to evaluate the safety, effectiveness and ease of use of
subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes
for the rehydration of pediatric patients with mild to moderate dehydration.
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